Institution Essentials

Step 1: Register to become a member of N3C Clinical to obtain access to meetings invitations, documents, discussion channels, and mailing lists.

• The N3C Clinical Registration Resources page provides links to relevant documents, resources, and communications.
• See the NCATS N3C webpage to find additional program resources and governance documents.

Step 2: Data Transfer Agreement

The Data Transfer Agreement (DTA) is a legal document that covers the terms of the transfer of data to N3C Clinical. This agreement covers the disclosure of a limited dataset from the contributing site and is signed by the transferring institution’s legal signatory and NCATS. For questions about executing the DTA, contact NCATSPartnerships@mail.nih.gov.

Step 3: IRB Submission & Approval

IRB approval is required to transfer a limited dataset to the N3C Clinical Data Enclave. The Johns Hopkins Medicine IRB serves as the central reviewing IRB that provides oversight of the transfer of data from your organization in accordance with the approved N3C Clinical protocol. If you choose to undergo review with your local IRB, a copy of your site’s approval letter must be submitted before moving forward.

This initial IRB approval is intended to cover only the contribution of data to N3C Clinical and does not cover research using N3C Clinical data. When both the DTA and IRB process is complete, you will receive an email notifying when you can transfer your data (see the NCATS FAQ under Contribute Data). For questions regarding N3C Clinical IRB requirements, please contact Tricia Francis before moving forward.

Other IRB Documents:

• Institutional Review Board (IRB) protocol
• Central IRB Approval Letter
• Local Context Questionnaire Sample
• Understanding Participating Site (pSite) Requirements

Step 4: Data Transfer and Acquisition Process

• Data Acquisition: Emily Pfaff at University of North Carolina, Chapel Hill will assist with the data transfer process. Once information is gathered from your organization, a script will be sent for pulling data in your site’s common data model format (PCORnet, OMOP, ACT, or TriNetX). Phenotype and Data Acquisition Office Hours are available for questions and discussion.
• Secure File Transfer Protocol (SFTP): After the steps above are complete, an SFTP site will be set up for your organization to both receive the data and have data quality checks performed by the Harmonization team.
• The average interval for data transfer is once a week; however, your organization can work with the N3C Clinical data transfer team to determine what works best for you.